Nov 12, 2018

Gottlieb: New drug approval criteria limited to opioids

FDA Commissioner Scott Gottlieb at a Senate hearing in 2017. (Photo: Zach Gibson/Getty Images)

Food and Drug Commissioner Scott Gottlieb said that if the agency raises the bar for new opioids — which he's open to — that new approach will be limited to opioids, and won't affect other drug categories.

Why it matters: There's long been a debate over whether new drugs should be approved or rejected in the context of what's already on the market. That might become the new rule for opioids, but Gottlieb made clear that the industry doesn't need to worry about a slippery slope.

I don’t think this same kind of standard would apply in other therapeutic areas. I think opioids are unique.”
— FDA Commissioner Gottlieb to Axios

The big picture: Currently, FDA approval is based on whether a drug is safe and effective. Some people argue that they should also be evaluated against existing drugs in the same arena.

  • This is essentially what Gottlieb is considering for opioids — requiring new drugs to add some new, distinct value to the market in order to be approved.
  • It's not surprising that he doesn't want to expand this into other classes of drugs; in his former life as a think tank scholar at the American Enterprise Institute, he wrote a paper laying out his argument against doing so.

Any changes would be clear in their scope, Gottlieb said. "I would do everything that I could from a policy standpoint ... to make it explicit that this was narrowly tailored to opioids for public health reasons.”

The other side: "The F.D.A.’s bar [for drug approval], while meaningful, often isn’t very useful for what physicians and patients really care about every day: how effective and safe drugs are compared with one another," Aaron Carroll, a professor at the Indiana University School of Medicine, wrote in the NYT in August.

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Acting Navy head apologizes for calling fired captain "stupid"

Acting Secretary of the Navy Thomas Modly testifies on Capitol Hill in December. Photo: Saul Loeb/AFP via Getty Images

Acting Navy Secretary Thomas Modly apologized Monday for calling Capt. Brett Crozier, the ousted commander of the USS Theodore Roosevelt, "too naive or too stupid" over his letter pleading for help following a coronavirus outbreak onboard.

The big picture: His apology came after President Trump told a news briefing earlier Monday he would "get involved" following a leak of Modly's remarks to the ship's crew on Crozier, who has since been diagnosed with coronavirus, which were obtained by CNN.

Go deeperArrowUpdated 21 mins ago - Politics & Policy

Coronavirus dashboard

Illustration: Sarah Grillo/Axios

  1. Global: Total confirmed cases as of 9:30 p.m. ET: 1,346,299 — Total deaths: 74,679 — Total recoveries: 276,636Map.
  2. U.S.: Total confirmed cases as of 9:30 p.m. ET: 367,507— Total deaths: 10,908 — Total recoveries: 19,598Map.
  3. 2020 update: Wisconsin Supreme Court blocks governor's attempt to delay in-person primary voting delayed until June.
  4. States latest: West Coast states send ventilators to New York and other states with more immediate need — Data suggest coronavirus curve may be flattening in New York, Gov. Andrew Cuomo said.
  5. World update: U.K. Prime Minister Boris Johnson moved to intensive care as coronavirus symptoms worsen.
  6. Stocks latest: The S&P 500 closed up 7% on Monday, while the Dow rose more than 1,500 points.
  7. What should I do? Pets, moving and personal health. Answers about the virus from Axios expertsWhat to know about social distancingQ&A: Minimizing your coronavirus risk.
  8. Other resources: CDC on how to avoid the virus, what to do if you get it.

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Former Vatican treasurer George Pell's sexual abuse convictions overturned

Cardinal George Pell at the County Court in Melbourne, Australia, in 2019. Photo: Michael Dodge/Getty Images

George Pell, the former Vatican treasurer, has won his appeal and had his child sexual abuse convictions overturned by Australia's High Court.

Why it matters: The cardinal became last year the highest-ranking Catholic Church official to go to trial and be convicted for sex abuse. But the High Court's ruling means he can be immediately released from prison, where he was serving a six-year sentence.

Go deeperArrowUpdated 1 hour ago - World